Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-685-4 | CAS number: 12023-91-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-06-16 to 2010-07-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data generated according to generally valid testing guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- In addition: Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Second revised edition, 2007. Chapter 3.4 Respiratory or Skin Sensitization
- Deviations:
- yes
- Remarks:
- During the challenge phase, 75% HCA (v/v) in acetone instead of undiluted HCA was used for topical application in the animals of positive control group. This was to avoid irritation (non-irritant dose at challenge phase) and had no impact on the validity.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA-method is only needed for new test plan.
Test material
- Reference substance name:
- Dodecairon strontium nonadecaoxide
- EC Number:
- 234-685-4
- EC Name:
- Dodecairon strontium nonadecaoxide
- Cas Number:
- 12023-91-5
- Molecular formula:
- Fe12O19.Sr
- IUPAC Name:
- dodecairon(3+) strontium(2+) nonadecaoxidandiide
- Details on test material:
- - Name of test material (as cited in study report): Strontiumhexaferrite ("Manipermpulver")
- Analytical purity: 100 % industrial strontiumferrite
- Impurities (identity and concentrations): see section 1.2 of the IUCLid5.2-file
- Composition of test material, percentage of components: see section 1.2 of the IUCLid5.2-file
- Lot/batch No.: S16/179/08
- Expiration date of the lot/batch: 12/2999
- Stability under test conditions: stable
- Storage condition of test material: air-conditioned romm temperature, non-sterile
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Vital River Laboratory Animal Technology Co. Ltd.; No 4, YangShan Road, Chaoyang District, Beijing, China
- Age at study initiation: Young adults
- Weight at study initiation: 680 - 944 g
- Housing: Conventional guinea pig cage system
- Diet (e.g. ad libitum): LabDiet 5025 Guinea Pig Diet
- Water (e.g. ad libitum): tap
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22°C
- Humidity (%): 30 - 70 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water.
- No. of animals per dose:
- 20. Plus 10 each in negative and positive control group.
- Details on study design:
- All animals were shaved on the back prior to the application. A gauze patch with approximate area of 6cm2 was loaded with 0.5 g test substance moistened with 80% (v/v) ethanol in water and applied topically to the shaved region of each animal in test group.
The gauze patch was held with an occlusive dressing secured by a surgical tape around the torso of the animal. The patch and dressing will be removed after 6-hour exposure.
In the negative and positive control group, the topical application was conducted in the same way as the test group; except that the gauze patch was fully loaded with negative control substance, i.e. 80% (v/v) ethanol in water or positive control substance, i.e. undiluted HCA, respectively.
The same application was repeatedly carried out on the same test area (cleared of hair if necessary) of each animal. The whole induction phase is outlined as follows:
Group Test Negative control Positive control
Date 16 Jun 2010 (Day 0)
22 Jun 2010 (Day 6)
23 Jun 2010 (Day 7)
24 Jun 2010 (Day 8)
29 Jun 2010 (Day 13)
30 Jun 2010 (Day 14)
01 Jul 2010 (Day 15)
Administration Topical application
Number of animal used 20 10 10
Dose level 0.5 g test substance loaded on an approximate 6 cm2 gauze patch and moistened with 200 µl 80% (v/v) ethanol in water approximate 6 cm2 gauze patch saturated with 500 µl 80% (v/v) ethanol in water approximate 6 cm2 gauze patch saturated with 500 µl undiluted HCA
Exposure period 6 hours
Dose Interval Once on above stated date
Challenge - topical application
Group Test Negative control Positive control
Date 14 Jul 2010 (Day 28)
Administration Topical application
Number of animal used 20 10 10
Dose level 0.5 g test substance loaded on an approximate 6 cm2 gauze patch and moistened with 200 µl acetone
approximate 6 cm2 gauze patch saturated with 500 µl 75% (v/v) HCA in acetone*
Exposure period 6 hours
Dose Interval Once on above stated date
Note: * During the induction phase, there was mild-to-moderate irritation after undiluted HCA topical application in animals of positive control group. Therefore, in challenge phase, 75% (v/v) HCA in acetone instead of undiluted HCA was used for topical application in the animals of positive control group to avoid irritation (non-irritant dose). - Positive control substance(s):
- yes
- Remarks:
- HCA = α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Positive control after 24 h after 48 h
219103186-01-00-PC1 1 0
219103186-01-00-PC2 2 2
219103186-01-00-PC3 2 1
219103186-01-00-PC4 2 2
219103186-01-00-PC5 1 0
219103186-01-00-PC6 2 1
219103186-01-00-PC7 2 1
219103186-01-00-PC8 1 1
219103186-01-00-PC9 1 1
219103186-01-00-PC10 2 1
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 g of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 g of the test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 g of the test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 g of the test substance. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 500 µl 80 % (V/V) ethanol in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 500 µl 80 % (V/V) ethanol in water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 500 µl 80 % (v/v) ethanol in water
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 500 µl 80 % (v/v) ethanol in water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 500 µl undiluted HCA
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 500 µl undiluted HCA. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 500µl undiluted HCA
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- No adverse effect was observed on all test animals during the observation period.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 500µl undiluted HCA. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: No adverse effect was observed on all test animals during the observation period..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the above results, strontium ferrite (“Manipermpulver”) did not produce skin sensitization in guinea pigs.
Strontium ferrite is to be considered as non-sensitizing to the skin. Classification is not required. - Executive summary:
The skin senzitisation potential of strontium ferrite was assessed in a test according to OECD 406 and UN-GHS. 20 animals (guinea pigs) were used for testing strontium ferrite, 10 anaimals 10 were in the negative and positive control group. The positive control group was exposed to undiluted HCA = α-Hexylcinnamaldehyde.
Observation of skin reactions was conducted at 24 and 48 hours after removal of the challenge patch. The skin reactions were recorded according to the grades shown in Magnusson and Kligman Grading Scale as follows:
Skin reaction
Grades
No visible change
Discrete or patchy erythema
Moderate and confluent erythema
Intense erythema and swelling
0
1
2
3
The average Magnusson and Kligman grade of animals in the negative control group is 0 (i.e. <1) during 24 and 48 hrs observations.
The percentage of animals shown Magnusson and Kligman grades of 1 or greater in test group is 0% (i.e. <15%) during 24 and 48 hrs observations.
The percentage of animals shown Magnusson and Kligman grades of 1 or greater in positive control group is 100% (i.e. >15%) during 24 and 48 hrs observations.
Based on the above results, strontium ferrite (“Manipermpulver”) did not produce skin sensitization in guinea pigs.
Strontium ferrite is to be considered as non-sensitizing to the skin. Classification is not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.